Chloroprocaine Spinal Anesthesia for Cervical Cerclage (CP Spinal)

Adverse Reaction to Spinal Anesthetic Clinical Trial

Official title:

Chloroprocaine Versus Bupivacaine Spinal Anesthesia for Cervical Cerclage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02862912
• Other study ID #: AAAQ0916
• Status: Completed
• Phase: Phase 4
• Start date: November 8, 2016
• Est. completion date: January 31, 2020

Study information

• Verified date: December 2020
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to determine whether or not spinal anesthesia with the local anesthetic drug, chloroprocaine, wears off faster than the local anesthetic drug, bupivacaine, and results in faster discharge from the post-anesthesia care unit after surgery.

Description:

This will be a prospective, randomized, double blind clinical trial. Subjects will be ASA I and II women ≥18 yrs old with a singleton pregnancy in the 1st or 2nd trimester of pregnancy undergoing cervical cerclage with spinal anesthesia. Patients will be randomly allocated to the chloroprocaine (CP) or bupivacaine group (BUP). Patients will receive spinal anesthesia with either chloroprocaine 50 mg with fentanyl 15 mcg or bupivacaine 9 mg with fentanyl 15 mcg.

Bupivacaine is the most common local anesthetic used for cervical cerclage with spinal anesthesia. Bupivacaine is safe and has been preferred over other medications such as lidocaine, because it is associated with a low incidence of a complication from spinal anesthesia known as "transient neurologic symptoms" - a condition where pain and cramping in the buttocks and lower extremities can be experienced for several days. Bupivacaine is a long-acting local anesthetic agent and therefore has the disadvantage of a prolonged anesthetic recovery that may last a few hours.

Chloroprocaine is a local anesthetic with a fast onset and short duration that may be used for spinal anesthesia for ambulatory procedures. Chloroprocaine is currently used at the research institution for spinal anesthesia for ambulatory surgical patients, especially for lower extremity orthopedic procedures such as knee arthroscopy, as well as for pregnant patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ASA I and II women

• 18-45 yrs old

• Singleton pregnancy

• Cervical cerclage 1st or 2nd trimester of pregnancy undergoing with spinal anesthesia

• Height 150 - 180 cm

• BMI = 40 kg/m2.

Exclusion Criteria:

• Any contraindication to neuraxial anesthesia (history of neurologic disease (e.g., multiple sclerosis, spinal stenosis, central or peripheral neuropathy)

• Pre-existing/chronic back pain

• Ester local anesthetic allergy, PABA allergy

• History of atypical cholinesterase (CP is metabolized by cholinesterase)

Related Conditions & MeSH terms

• Adverse Reaction to Spinal Anesthetic
• Maternal Care for Cervical Incompetence
• Uterine Cervical Incompetence

Intervention

Drug:
• Chloroprocaine
Administered as a single injection or continuously through an indwelling catheter - 50 mg
• Bupivacaine
A dextrose Solution is usually given as an injection - 9 mg (1.4 ml)
• Fentanyl
15 mcg Fentanyl will be included int he spinal anesthetic in both groups
• Saline
Preservative free normal saline (0.3 ml) to bring the volume to ~ 2 ml

Locations

Country	Name	City	State
United States	New York Presbyterian Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Camponovo C, Wulf H, Ghisi D, Fanelli A, Riva T, Cristina D, Vassiliou T, Leschka K, Fanelli G. Intrathecal 1% 2-chloroprocaine vs. 0.5% bupivacaine in ambulatory surgery: a prospective, observer-blinded, randomised, controlled trial. Acta Anaesthesiol Scand. 2014 May;58(5):560-6. doi: 10.1111/aas.12291. Epub 2014 Mar 6. — View Citation

Hejtmanek MR, Pollock JE. Chloroprocaine for spinal anesthesia: a retrospective analysis. Acta Anaesthesiol Scand. 2011 Mar;55(3):267-72. doi: 10.1111/j.1399-6576.2010.02371.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Resolution of Motor Block	The mean difference between groups in time between the end of spinal injection (t IT) to time for no motor block (t motor), i.e. tIT - T motor. Motor block will be assessed using the Bromage scale: Bromage Scale I = free movement of the legs and feet = no block II = able to flex knees, with free movement of feet = partial (33%) block III = unable to flex knees, but with free movement of the feet = almost complete (66%) block IV = unable to move legs or feet = complete block (100%)	3 hours
Secondary	Time to Ambulate	Time from spinal anesthesia placement to ability to ambulate.	5 hours
Secondary	Time to Void	Time from spinal anesthesia injection to ability to void spontaneously.	5 hours